近日，歐洲藥品管理局EDQM-OMCL發布了新的質量管理文件《結果的評估和報告》，包含1個核心文件和5個附錄（附錄1 修約、附錄2 定量測試結果的評估、附錄3 OOS結果的確認、附錄3.1 概述-初始OOS結果的確認、附錄3.2 定量測試OOS結果的確認、附錄3.3 定量測試OOS結果的確認、附錄3.4：與OOS結果確認有關的動物試驗的特殊考慮），內容包括如下：
1. Introduction
介紹
2. Scope
范圍
3. Glossary and definitions (also used in the text of the Annexes)
術語和定義（也適用于附錄文本）
4. Evaluation of testing results
測試結果評估
4.1 Testing results
測試結果
4.1.1 Pre-testing phase
預測試階段
4.1.2. Testing phase
測試階段
4.1.2.1. Method verification
方法確認
4.1.2.2. Generation of raw data for sample analysis
樣品分析原始數據的生成
4.1.2.3. Review of the raw data
原始數據的審核
4.1.2.4. Calculation of the results
結果的計算
4.1.2.5. Averaging and Rounding of the results:
結果的平均和修約
4.1.2.6. Checking validity of results
結果的有效性檢查
4.2 Ensuring validity of testing results (including monitoring and trending)
確保測試結果的有效性（包括監控和趨勢）
4.3 Decision rules (as defined in ISO/IEC 17025:2017)
決策規則（定義見ISO/IEC 17025：2017）
4.4 Out-of-specification (OOS) results
OOS結果
4.4.1 Failure investigation of OOS results
OOS結果的調查
4.4.2 Retest programme for confirmation of OOS results
用于確認OOS結果的復測程序
4.5 Review and authorisation of testing results
測試結果的審核和批準
5. Reporting of results
結果的報告
6. References
參考文獻
Annex 1. Rounding
附錄1 修約
Annex 2. Evaluation of results from quantitative testing
附錄2 定量測試結果的評估
Annex 3. Verification of OOS results
附錄3 OOS結果的確認
Annex 3.1: General Introduction - Verification of Initial out-of-specification (OOS) results
附錄3.1 概述-初始OOS結果的確認
Annex 3.2: Verification of OOS results in quantitative testing
附錄3.2 定量測試OOS結果的確認
Annex 3.3: Verification of OOS results in qualitative testing
附錄3.3 定量測試OOS結果的確認
Annex 3.4: Special considerations for animal testing in connection with verification of OOS results
附錄3.4：與OOS結果確認有關的動物試驗的特殊考慮
文件中指出，數據的平均取決于樣本和所使用的方法。
Averaging of the data depends on the sample and the method used.
數據的平均取決于樣本和所使用的方法。
Examples
示例
In the potentiometric determination of pH value, the reportable result is determined by calculating the average of a number (for example 3) of measurements of a sample, and this average is reported as the test result.
在pH值的電位測定中，通過計算樣品測量值的平均值（例如3）來確定報告結果，并將該平均值報告為測試結果。
For an HPLC method for assay of active substance, one independent determination has been carried out by three consecutive injections (replicates) of the same sample preparation. The reportable result is determined by averaging the peak responses from these replicates obtained from the same preparation. The assay result is calculated using the peak response average. This determination is considered as one test and one reportable result, and should fulfil the predefined acceptable precision criteria, e.g. based on validation criteria.
對于用于測定活性物質的HPLC方法，已通過連續三次進針（重復）相同的樣品溶液進行一次獨立的測定。通過對從同一溶液中獲得的這些重復的峰響應求平均值來確定可報告的結果。使用峰值響應平均值計算測定結果。該測定被視為一項測試和一個可報告的結果，并應滿足既定的的可接受精度標準，例如基于驗證標準。
同時也提出：
When evaluating results of microbiological contamination tests it is important to note that the contamination may not be distributed evenly throughout a product batch or sample. Homogeneity of a microbiological sample, for example, by thorough mixing prior to testing, does not imply a constant level of microbial cells throughout test sample units. Where the contamination is not uniformly distributed throughout a product batch or sample, i.e. contamination is detected in some but not all of the units, it may not be valid to pool and then average the count results from multiple units of the sample as this could average out a non-compliant result to a compliant result.
在評估微生物污染測試結果時，重要的是要注意污染可能不均勻地分布在整個產品批次或樣品中。微生物樣品的均勻性，例如，通過在測試前徹底混合，并不意味著整個測試樣品單元的微生物細胞水平恒定。如果污染在整個產品批次或樣品中分布不均勻，即在某些而非全部單位中檢測到污染，則合并然后平均多個樣品單位的計數結果可能無效，因為這可能會將不合格結果平均為合格結果。
